Duns Number:079299318
Device Description: HepCheck P214 - Abnormal 15/box
Catalog Number
DCP214-A
Brand Name
HepCheck Whole Blood Control
Version/Model Number
DCP214-A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K944691,K944691
Product Code
GGN
Product Code Name
Plasma, Coagulation Control
Public Device Record Key
ea2450b2-4c04-417c-ab54-093ce76af99b
Public Version Date
August 31, 2022
Public Version Number
5
DI Record Publish Date
September 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 43 |